Kornimate/medical-research-clean huggingface dataset:
iodine i 131 ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer

Conditions: Liver Cancer

Summary: rationale: iodine i 131 ethiodized oil may help prevent or delay the recurrence of cancer. it is not yet known whether iodine i 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer. purpose: this randomized phase iii trial is studying iodine i 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

objectives: primary * determine whether treatment with adjuvant intra-arterial iodine i 131 ethiodized oil reduces the percentage of tumor recurrence in patients with curatively treated hepatocellular carcinoma. secondary * evaluate the overall and recurrence-free survival of these patients. * evaluate the deterioration of liver function in these patients. * evaluate the toxicity of intra-arterial iodine i 131 ethiodized oil in these patients. outline: this is a multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive an intra-arterial infusion of iodine i 131 ethiodized oil. * arm ii: patients receive an intra-arterial infusion of unlabeled ethiodized oil. after completion of study treatment, patients are followed periodically for 5 years.

Eligibility criteria:
disease characteristics: * diagnosis of hepatocellular carcinoma (hcc) * alpha-fetoprotein \< 20 ng/ml * must have undergone curative treatment for hcc within the past 8-20 weeks, including 1 of the following: * curative resection * alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules \< 5 cm in diameter) * no ascites * no other intrahepatic involvement or nodule progression as assessed by ultrasound * no extrahepatic metastases patient characteristics: * who performance status 0-2 * anc ≥ 1,500/mm³ * platelet count ≥ 50,000/mm³ * bilirubin ≤ 51 μmol/l * creatinine ≤ 120 μmol/l * not pregnant or nursing * negative pregnancy test * child-pugh score \< 8 (class b) * no decompensated cirrhosis * no encephalopathy * no uncontrolled bleeding * no portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or portal reflux by doppler or ct scan * no unstable medical or surgical disease * no contraindication to vascular arteriography * no history of complications after injection of iodine contrast agents * not incarcerated prior concurrent therapy: * see disease characteristics * recovered from all prior therapy * no prior hormonal treatment, including tamoxifen and somatostatin analogs * no prior systemic chemotherapy

Keywords: adult primary hepatocellular carcinoma advanced adult primary liver cancer localized resectable adult primary liver cancer localized unresectable adult primary liver cancer
lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy

Conditions: Iron Deficiency Anemia of Pregnancy

Summary: the study aims to compare the efficacy and the safety of lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.

the study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups . group one lactoferrin group group two ferrous sulphate group

Eligibility criteria:
inclusion criteria: * pregnant women from 20 to 40 years * iron deficiency anemia (mild and moderate) * gestational age 13 to 26 weeks * singleton viable pregnancy. exclusion criteria: * history of anemia due to chronic blood loss * hemolytic anemia * severe anemia * history of peptic ulcer
virtual reality to alleviate claustrophobia during mri

Conditions: Claustrophobia

Summary: this study evaluates if our virtual reality (vr) simulation inside the mri efficiently alleviates symptoms of claustrophobia for patients during the mri examination.

anxiety of claustrophobic patients during mri scan leads to movements of patients (which cause imaging artefacts), interruptions or even abortions of imaging scans, eventually requiring to reschedule the examination. improving these symptoms by creating a vr experiences adapted to the physical constraints of the mri environment, such as "disappearing the scanner", not only improves the subjective experience of the participant, but has immediate impacts the time spent on the examination, on personnel costs, and resource availability (scanner time). this study aims at comparing claustrophobic patients in an a\|b group design with or without vr intervention. primary outcomes include subjective reports from patients (acceptability and demand) and practitioners (implementation, practicality, adaptation, integration, expansion). secondary outcomes include scanning efficacy based e.g. on the imaging quality, number of times a scan is interrupted by the user and the total duration of a scan. another non-claustrophobic patients' group will be tested for for obtaining feedback on the general benefit of vr immersion on patients' experience.

Eligibility criteria:
inclusion criteria: * indicating suffering from claustrophobia * be aged between 18 and 40 year-old * being able to give consent * being able to understand and speak french or english * being mri-compatible exclusion criteria: * epilepsy or illnesses affecting the brain, such as hiv, lyme disease or meningitis * psychiatric disorders, such as schizophrenia, autism, obsessive compulsive disorder. * history of 1 year or more of addiction to drugs such as cannabis, alcohol, cocain, heroine, lsd. * taking sleeping pills or anti-anxiety medication before the exam
safety and efficacy of crizotinib (regulatory post marketing commitment plan)

Conditions: Non-small Cell Lung Cancer

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the lpd (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes crizotinib (xalkori) should be registered.

Eligibility criteria:
inclusion criteria: * all the patients whom an investigator prescribes xalkori. (patients need to be administered crizotinib (xalkori) in order to be enrolled in this all cases surveillance.) exclusion criteria: * patients not administered xalkori in spite of enrolled.

Keywords: safety all cases surveillance in japan alk-positive unresectable advanced and/or recurrent non-small cell lung cancer
efficacy and safety of sr1375 in adult patients with cap

Conditions: Community-acquired Pneumonia

Summary: this is a phase 2 study to evaluate the efficacy and safety of sr1375 in hospitalized adult patients with cap. patients will receive sr1375 or placebo for 8 weeks. the study duration for each patient is up to 10 weeks.

this is a randomized, double-blind and placebo-controlled phase 2 study comparing sr1375 with placebo in adult patients with cap. it consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. baseline niaid-os 8-point scale score will be checked for eligibility. around 240 eligible subjects will be recruited and randomized into four arms at 1:1:1:1 ratio to receive sr1375 0.3mg, sr1375 1mg, sr1375 3mg or placebo orally daily for 56 days. subjects, investigators, all clinical study site staffs, and the sponsor will remain blinded to treatment assignment during the study. subjects will receive regular treatments as per his/her condition by investigator. after completion of double-blind treatment period, subjects will continue to complete the safety follow-up for 14 days.

Eligibility criteria:
key inclusion criteria: * age ≥ 18 years, male or female * diagnosis of cap * baseline niaid-os 8-point scale score of 5 points and transcutaneous oxygen saturation ≤ 93% without oxygen inhalation or 6 points. (5 points refer to hospitalization with oxygen therapy; 6 points refer to hospitalization with high flow oxygen therapy or non-invasive mechanical ventilation. high oxygen flow refers to ≥ 4 l/min.) * with ≥ 1 high risk factors including chronic obstructive pulmonary disease (copd), pulmonary fibrosis, type 2 diabetes, chronic kidney disease, coronary heart disease, age ≥ 65 years, moderate obesity (body mass index\>32.5kg/m2), etc. * participants of women of childbearing potential(wocbp) and male participants with wocbp partners must agree to use one or more effective contraceptive methods during the treatment period and until 90 days after the last administration. key exclusion criteria: * have received or require invasive mechanical ventilation or ecmo within 24 hours. * with septic shock requiring vasoactive drugs. * unable to swallow capsules due to consciousness disorders or other reasons. * with active tuberculosis, severe asthma, hyperglycemia, hyperosmolality, ketoacidosis or diabetes foot. * have experienced unstable angina, acute myocardial infarction, or stroke within the past 3 months. * have taken glucocorticoids with an average daily dose \>40 mg methylprednisolone or equivalent dose within the past 3 days.

Keywords: community acquired pneumonia sr1375
pet/ct whole-body dynamic acquisition at fdg to metastatic melanoma under immunotherapy

Conditions: Metastatic Melanoma

Summary: the value of 4d body-to-whole dynamic acquisition in fdg pet / ct to differentiate progression / pseudo-progression during the first therapeutic assessment (pet1) of metastatic melanoma treated with immune checkpoint inhibitors (ici)to predict the progression of the disease..


Eligibility criteria:
inclusion criteria: * patient old ≥ 18 years * with metastatic melanoma * treated with anti-pd1 : nivolumab or pembrolizumab or combo ipi-nivo * having formulated a non-opposition exclusion criteria: * - minor patient \< 18 years * pregnancy or breastfeeding * other type of tumor than metastatic melanoma * non-eligibility for the examination * refusal of participation
effects of ozone therapy as an adjunct to periodontal treatment

Conditions: Periodontitis

Summary: this randomized, placebo controlled, split-mouth clinical study trial evaluates the effects of ozone therapy on clinical and biochemical parameters. total of 20 participants completed the study . periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. all participants were treated non-surgically. topical gaseous ozone was applied into periodontal pockets. gingival crevicular fluid pentraxin-3 (ptx-3), interleukin-1β (il-1β) and high sensitivity c-reactive protein (hs-crp) were evaluated.

ozone therapy (ot) is very popular in medicine. especially it use for wound healing and antibacterial properties. this randomized, placebo controlled, randomized split-mouth clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters. total of 20 participants completed the study (10 males, 10 females). periodontal parameters, including plaque index (pi), gingival index (gi), probing depth (pd), percentage of bleeding on probing, percentage of pockets deeper than 5 mm and clinical attachment level (cal), and percentage of ≥3 mm clinical attachment level. periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. all participants were treated non-surgically. topical gaseous ozone was applied into periodontal pockets twice a week for 2 weeks during active periodontal therapy. gingival crevicular fluid pentraxin-3 (ptx-3), interleukin-1β (il-1β) and high sensitivity c-reactive protein (hs-crp) were evaluated.

Eligibility criteria:
inclusion criteria: * 18 to 64 years of age * generalized chronic periodontitis(armitage, 1999) * systemically healthy * more than 20 teeth (excluding third molars) exclusion criteria: * periodontal treatment within 6 months * antibiotic use within the previous 3 months * pregnancy and lactation * past or current smoking and alcohol consumption * contraindications for ot * patients with class ii and iii furcation defects(staffileno, 1969)
a belgian registry of humira® (adalimumab) in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis ( proact )

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Summary: this is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with humira (adalimumab).


Eligibility criteria:
inclusion criteria: * patients with ongoing humira (adalimumab) treatment who have been prescribed humira (adalimumab) within local reimbursement guidelines. * patients must be willing to consent to data being collected and provided to abbott laboratories. exclusion criteria: * contraindications according to the summary of product characteristics. * patients who are actually followed in the realise registry (m03-634 nct00234884).

Keywords: multicenter study
tolerability of a novel spectacle design with reduced peripheral contrast

Conditions: Myopia

Summary: prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

this feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.

Eligibility criteria:
inclusion criteria: * ages between 6 and 12 years * myopia between -1.00 and -4.00 d exclusion criteria: * participating in any clinical or other research study * contact lens wearer
cerebral reorganization of stroke patients after repetitive transcranial magnetic stimulation by neuroimaging analysis

Conditions: Stroke

Summary: the study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor imaging.


Eligibility criteria:
inclusion criteria: 1. stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image, 2. right-handed, 3. without memory loss or intelligence disorder, 4. never suffered stroke before. exclusion criteria: 1. direct damage to the cerebral cortex, 2. a history of cerebral vessel disease, 3. tendency to hemorrhage or existed brain hemorrhage, 4. epilepsy or other mental disorders, 5. any mri contraindications.

Keywords: ischemic stroke functional magnetic resonance imaging (fmri) repetitive transcranial magnetic stimulation (rtms) brain reorganization
indocyanine green and near-infrared fluorescence imaging to detect sentinel lymph nodes in patients with endometrial cancer

Conditions: Endometrial Cancer; Sentinel Lymph Node Detection

Summary: patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, indocyanine green (icg). icg spreads through the lymphatic system, and will be visualized using near-infrared (nir) imagers. upon visualization of the path of the icg, sentinel lymph nodes (slns), the first nodes to receive drainage from the primary tumor, will be identified. slns will be surgically removed and provided to pathology for evaluation. non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to pathology for evaluation. a positive sln may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.


Eligibility criteria:
inclusion criteria: * adult women patients (\>18 years of age and \<90 years of age) * research authorization (consent) * pre-operative diagnosis of clinical stage 1 endometrial cancer * pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size * scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy exclusion criteria: * severe coagulopathy or severe thrombocytopenia * severe anemia * severe cardio-pulmonary comorbidities demanding minimization of operative time * history of liver disease * iodide allergy * emergent operation * additional surgical risk as determined during surgery at the discretion of the attending * impaired capacity to make informed medical decisions

Keywords: endometrial cancer sentinel lymph node indocyanine green near infrared imaging
open label study of posaconazole in the treatment of invasive fungal infections (study p00041)

Conditions: Mycoses

Summary: this study is designed to evaluate the safety, tolerance and efficacy of posaconazole (sch 56592) under an open label, treatment protocol for subjects with invasive fungal infections: a: which are refractory or resistant to standard antifungal therapies; b: for which there are currently no effective therapies; c: with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; d: with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

the current clinical trial is designed to provide posaconazole (sch 56592) to subjects with invasive fungal infections a)which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. secondly, this clinical trial is also designed to provide posaconazole (sch 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. this clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (sch 56592) against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.

Eligibility criteria:
inclusion criteria * proven or probable invasive fungal infections according to eortc/msg criteria. * ifi are documented to be refractory to standard antifungal therapy or intolerant to standard therapy. * able to take oral medication or take medication via enteral feeding tube. exclusion criteria * concurrent progressive neurological disease (except if due to invasive fungal infection) * use of medications that are known to interact with azoles and that may lead to life-threatening side to effects. * prior enrollment in this study. * subjects with a life expectancy of less than 72 hours.

Keywords: aspergillosis, candidiasis, cryptococcosis,
a six week study of the pain relieving effects of celecoxib 200 mg twice daily compared to tramadol 50 mg four times daily in patients with chronic low back pain

Conditions: Low Back Pain

Summary: to compare the analgesic effectiveness of celecoxib and tramadol in subjects with chronic low back pain measured by the numerical rating scale (nrs-pain) at week 6


Eligibility criteria:
inclusion criteria: * the subject presents with duration of chronic low back pain of \> 3 months requiring regular use of analgesics (\> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used exclusion criteria: * the subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)

Keywords: chronic low back pain
improving our understanding of suicidal ideation in cancer survivors

Conditions: Suicidal Ideation

Summary: the goal of this project is to assess the feasibility of collecting physiological and psychological data that will allow for preliminary investigation of predictors of suicidal ideation in an ambulatory cancer population already seeking psychosocial support.

exploratory analyses will be the first step to establishing possible predictive relationships. the long-term goal of this research is to identifying an integrated model of suicidal ideation in cancer, so that providers will be better able to identify appropriate screening methods to target patients at high risk for suicide. this information will ultimately inform the development of psychosocial interventions that specifically address the variables that increase suicide risk in patients with cancer.

Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision to sign and date the consent form. 2. stated willingness to comply with all study procedures and be available for the duration of the study. 3. be male or female, aged 18 or older. 4. ambulatory oncology patients at the university of colorado cancer center who are being provided psychosocial support services; specifically, having had at least one in-person meeting with a doctoral level clinical/counseling psychologist or masters level social worker. 5. valid and private email account. exclusion criteria:
phase i study of ccrt as adjuvant treatment for stage ii/iii operable rectal cancer.

Conditions: Rectal Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose and safety of s-1 plus radiotherapy for patients with rectal cancer

this stage i study is designed to evaluate the appropriate dose of s-1 plus radiotherapy for patients with r0 resection of rectal cancer for stage ii-iii patients(ajcc 7th). to evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

Eligibility criteria:
inclusion criteria: * r0 resection of histologically proved stage ii/iii rectal cancer; * 18-75 years old; * no previous radiotherapy or chemotherapy for rectal cancer; * performance status of ecog 0,1; * adequate organ function defined as below: i. wbc ≥ 4,000/mm\^3 ii. anc ≥ 1,500/mm\^3 iii. hemoglobin ≥ 10g/dl iv. platelet ≥ 100,000/m\^3 v. total bilirubin ≤ 1.5uln vi. ast/alt ≤ 1.5uln vii. serum creatinine ≤ 1.5uln or creatinine clearance rate ≥ 60ml/min、urea nitrogen ≤ 1.5uln viii. protein in urine dipstick test\ 1+ ,total protein in urea must \<500mg within 24 hours * able to receive oral administration * informed consent exclusion criteria: * hypersensitive to s-1 or its excipients * pulmonary fibrosis or interstitial pneumonitis found within 28 days prior to registration * significant co-morbid medical conditions, including, but not limited to, heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes * received any investigational drug or anti-cancer agent * pregnant or lactating female or pregnancy test positive * severe mental disorder * judged ineligible by physicians for participation in the study due to safety concern.

Keywords: rectal cancer s-1 chemoradiotherapy phase i